Stent for Prosthetic Heart Valves

ABSTRACT

A stented valve including a stent structure including a generally tubular body portion having a first end, a second end, an interior area, a longitudinal axis, and a plurality of vertical wires extending generally parallel to the longitudinal axis around a periphery of the body portion, wherein the plurality of vertical wires includes multiple commissure wires and at least one structural wire positioned between adjacent commissure wires, and a plurality of V-shaped wire structures having a first end, a second end, and a peak between the first and second ends, wherein a first end of each V-shaped structure extends from a first vertical wire and a second end of each V-shaped structure extends from a second vertical wire that is adjacent to the first vertical wire, wherein each V-shaped structure is oriented so that its peak is facing in the same direction relative to the first and second ends of the body portion, and a valve structure including a plurality of leaflets attached to the stent structure within the tubular body portion.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims priority to U.S. Provisional ApplicationNo. 61/062,207, filed Jan. 24, 2008, and titled “Delivery Systems andMethods of Implantation for Prosthetic Heart Valves”, the entirecontents of which is incorporated herein by reference in its entirety.

TECHNICAL FIELD

The present invention relates to prosthetic heart valves. Moreparticularly, it relates to devices, methods, and delivery systems forpercutaneously implanting prosthetic heart valves.

BACKGROUND

Diseased or otherwise deficient heart valves can be repaired or replacedusing a variety of different types of heart valve surgeries. Typicalheart valve surgeries involve an open-heart surgical procedure that isconducted under general anesthesia, during which the heart is stoppedwhile blood flow is controlled by a heart-lung bypass machine. This typeof valve surgery is highly invasive and exposes the patient to a numberof potentially serious risks, such as infection, stroke, renal failure,and adverse effects associated with use of the heart-lung machine, forexample.

Recently, there has been increasing interest in minimally invasive andpercutaneous replacement of cardiac valves. Such surgical techniquesinvolve making a very small opening in the skin of the patient intowhich a valve assembly is inserted in the body and delivered to theheart via a delivery device similar to a catheter. This technique isoften preferable to more invasive forms of surgery, such as theopen-heart surgical procedure described above. In the context ofpulmonary valve replacement, U.S. Patent Application Publication Nos.2003/0199971 A1 and 2003/0199963 A1, both filed by Tower, et al.,describe a valved segment of bovine jugular vein, mounted within anexpandable stent, for use as a replacement pulmonary valve. Thereplacement valve is mounted on a balloon catheter and deliveredpercutaneously via the vascular system to the location of the failedpulmonary valve and expanded by the balloon to compress the valveleaflets against the right ventricular outflow tract, anchoring andsealing the replacement valve. As described in the articles:“Percutaneous Insertion of the Pulmonary Valve”, Bonhoeffer, et al.,Journal of the American College of Cardiology 2002; 39: 1664-1669 and“Transcatheter Replacement of a Bovine Valve in Pulmonary Position”,Bonhoeffer, et al., Circulation 2000; 102: 813-816, the replacementpulmonary valve may be implanted to replace native pulmonary valves orprosthetic pulmonary valves located in valved conduits.

Various types and configurations of prosthetic heart valves are used inpercutaneous valve procedures to replace diseased natural human heartvalves. The actual shape and configuration of any particular prostheticheart valve is dependent to some extent upon the valve being replaced(i.e., mitral valve, tricuspid valve, aortic valve, or pulmonary valve).In general, the prosthetic heart valve designs attempt to replicate thefunction of the valve being replaced and thus will include valveleaflet-like structures used with either bioprostheses or mechanicalheart valve prostheses. In other words, the replacement valves mayinclude a valved vein segment that is mounted in some manner within anexpandable stent to make a stented valve. In order to prepare such avalve for percutaneous implantation, the stented valve can be initiallyprovided in an expanded or uncrimped condition, then crimped orcompressed around the balloon portion of a catheter until it is as closeto the diameter of the catheter as possible.

Other percutaneously-delivered prosthetic heart valves have beensuggested having a generally similar configuration, such as byBonhoeffer, P. et al., “Transcatheter Implantation of a Bovine Valve inPulmonary Position.” Circulation, 2002; 102:813-816, and by Cribier, A.et al. “Percutaneous Transcatheter Implantation of an Aortic ValveProsthesis for Calcific Aortic Stenosis.” Circulation, 2002;106:3006-3008, the disclosures of which are incorporated herein byreference. These techniques rely at least partially upon a frictionaltype of engagement between the expanded support structure and the nativetissue to maintain a position of the delivered prosthesis, although thestents can also become at least partially embedded in the surroundingtissue in response to the radial force provided by the stent andballoons that are sometimes used to expand the stent. Thus, with thesetranscatheter techniques, conventional sewing of the prosthetic heartvalve to the patient's native tissue is not necessary. Similarly, in anarticle by Bonhoeffer, P. et al. titled “Percutaneous Insertion of thePulmonary Valve.” J Am Coll Cardiol, 2002; 39:1664-1669, the disclosureof which is incorporated herein by reference, percutaneous delivery of abiological valve is described. The valve is sutured to an expandablestent within a previously implanted valved or non-valved conduit, or apreviously implanted valve. Again, radial expansion of the secondaryvalve stent is used for placing and maintaining the replacement valve.

Although there have been advances in percutaneous valve replacementtechniques and devices, there is a continued desire to provide differentdesigns of cardiac valves that can be implanted in a minimally invasiveand percutaneous manner.

SUMMARY

The replacement heart valves of the invention each include a stent towhich a valve structure is attached. The stents of the invention includea wide variety of structures and features that can be used alone or incombination with features of other stents of the invention. Inparticular, these stents provide a number of different docking and/oranchoring structures that are conducive to percutaneous deliverythereof. Many of the structures are thus compressible to a relativelysmall diameter for percutaneous delivery to the heart of the patient,and then are expandable either via removal of external compressiveforces (e.g., self-expanding stents), or through application of anoutward radial force (e.g., balloon expandable stents). The devicesdelivered by the delivery systems described herein can be used todeliver stents, valved stents, or other interventional devices such asASD (atrial septal defect) closure devices, VSD (ventricular septaldefect) closure devices, or PFO (patent foramen ovale) occluders.

Methods for insertion of the replacement heart valves of the inventioninclude delivery systems that can maintain the stent structures in theircompressed state during their insertion and allow or cause the stentstructures to expand once they are in their desired location. Inaddition, delivery methods of the invention can include features thatallow the stents to be retrieved for removal or relocation thereof afterthey have been deployed or partially deployed from the stent deliverysystems. The methods may include implantation of the stent structuresusing either an antegrade or retrograde approach. Further, in many ofthe delivery approaches of the invention, the stent structure isrotatable in vive to allow the stent structure to be positioned in adesired orientation.

One embodiment of a stent of the invention comprises a tubular wirestructure including multiple longitudinal wires that extend generallyparallel to the longitudinal axis of the stent. The wires are spacedfrom each other around the periphery of the stent. The stent furtherincludes tissue attachment features, such as commissure attachmentposts. In one embodiment, the stent includes three commissure attachmentposts, where each of the posts is used as a connection location for oneof the commissures of a tri-leaflet valve that will be attached thereto.Alternatively, more or less than three posts can be provided for a valvehaving more or less than three leaflets, respectively. The stent furtherincludes multiple V-shaped wire structures between a pair of wiresand/or between a wire and an adjacent attachment post. In oneembodiment, the stent includes three V-shaped wires that arelongitudinally spaced from each other along the height of the stentbetween each adjacent pair of wires or between a wire and an adjacentpost. There may alternatively be more or less than three V-shaped wiresspaced longitudinally from each other.

A first end of each V-shaped wire extends from a first end of anattachment post or wire, and a second end of wire extends from the firstend of an adjacent wire or attachment post. In this way, a peak of eachV-shaped wire will be positioned generally in the center of the spacebetween adjacent longitudinal wires, and will be directed toward asecond or inlet end of the stent. All or some of the wires can be flaredat least slightly outward relative to the outer tubular shape of thestent, thereby creating integrated flange structures that can be used tocapture the native leaflets when the stent is implanted in a patient.Each wire is spaced longitudinally from a corresponding wire, and eachwire is spaced longitudinally from a corresponding wire.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be further explained with reference to theappended Figures, wherein like structure is referred to by like numeralsthroughout the several views, and wherein:

FIG. 1 is a perspective view of an embodiment of a stent in accordancewith the invention;

FIG. 2 is a front view of the stent of FIG. 1;

FIG. 3 is a top view of the stent of FIG. 1;

FIG. 4 is a top view of a cutting pattern for the stent of FIG. 1;

FIG. 5 is a perspective view of an embodiment of a stent in accordancewith the invention;

FIG. 6 is a front view of the stent of FIG. 5;

FIG. 7 is a top view of the stent of FIG. 5;

FIG. 8 is a top view a cutting pattern for the stent of FIG. 5;

FIG. 9 is a perspective view of an embodiment of a stent in accordancewith the invention;

FIG. 10 is a front view of the stent of FIG. 9;

FIG. 11 is a perspective view of a “ladder” mechanism used forattachment of tissue to a stent;

FIG. 12 is a top view of two ladder mechanisms of FIG. 11 positionedrelative to leaflets and a stent;

FIG. 13 is a perspective view of the ladder mechanisms, tissue, andportion of a stent illustrated in FIG. 12;

FIG. 14 is a top schematic view of the stent arrangement of FIGS. 12 and13;

FIG. 15 is a perspective view of a “slot bar” mechanism used forattachment of tissue to a stent;

FIG. 16 is a top view of a slot bar mechanism of FIG. 15 positionedrelative to leaflets and a stent;

FIG. 17 is perspective view of the slot bar mechanism, tissue, andportion of a stent illustrated in FIG. 16;

FIG. 18 is a top view of a “padded slot bar” mechanism positionedrelative to leaflets and a stent;

FIG. 19 is a perspective view of the padded slot bar mechanism, tissue,and portion of a stent illustrated in FIG. 18;

FIG. 20 is a perspective view of a “buckle” mechanism positionedrelative to leaflets and a stent;

FIG. 21 is a top view of the portion of a stent, leaflets, and bucklemechanism illustrated in FIG. 20;

FIG. 22 is another perspective view of the portion of a stentillustrated in FIG. 20;

FIG. 23 is a perspective view of a “padded buckle” mechanism positionedrelative to leaflets and a stent;

FIG. 24 is a top view of the portion of a stent, leaflets, and paddedbuckle mechanism illustrated in FIG. 23;

FIG. 25 is another perspective view of the portion of a stentillustrated in FIG. 23; and

FIG. 26 is a perspective view of another stent embodiment of theinvention.

DETAILED DESCRIPTION

As referred to herein, the prosthetic heart valves used in accordancewith the various devices and methods of heart valve delivery may includea wide variety of different configurations, such as a prosthetic heartvalve having tissue leaflets or a synthetic heart valve havingpolymeric, metallic, or tissue-engineered leaflets, and can bespecifically configured for replacing any heart valve. That is, whilemuch of the description herein refers to replacement of aortic valves,the prosthetic heart valves of the invention can also generally be usedfor replacement of native mitral, pulmonic, or tricuspid valves, for useas a venous valve, or to replace a failed bioprosthesis, such as in thearea of an aortic valve or mitral valve, for example.

Although each of the valves used with the delivery devices and methodsdescribed herein would typically include leaflets attached within aninterior area of a stent, the leaflets are not shown in many of theillustrated embodiments for clarity purposes. In general, the stentsdescribed herein include a support structure comprising a number ofstrut or wire portions arranged relative to each other to provide adesired compressibility, strength, and leaflet attachment zone(s) to theheart valve. Other details on particular configurations of the stents ofthe invention are also described below; however, in general terms,stents of the invention are generally tubular support structures, andleaflets will be secured within the inner portion of the supportstructure to provide a valved stent. The leaflets can be formed from avariety of materials, such as autologous tissue, xenograph material, orsynthetics as are known in the art. The leaflets may be provided as ahomogenous, biological valve structure, such as a porcine, bovine, orequine valve. Alternatively, the leaflets can be provided independent ofone another (e.g., bovine or equine pericardial leaflets) andsubsequently assembled to the support structure of the stent. In anotheralternative, the stent and leaflets can be fabricated at the same time,such as may be accomplished using high strength nano-manufactured NiTifilms of the type produced at Advanced Bio Prosthetic Surfaces Ltd.(ABPS) of San Antonio, Tex., for example. The support structures aregenerally configured to accommodate three leaflets; however, thereplacement prosthetic heart valves of the invention can be configuredto incorporate more or less than three leaflets.

In more general terms, the combination of a support structure with oneor more leaflets can assume a variety of other configurations thatdiffer from those shown and described, including any known prostheticheart valve design. In certain embodiments of the invention, the supportstructure with leaflets utilize certain features of known expandableprosthetic heart valve configuration, whether balloon expandable,self-expanding, or unfurling (as described, for example, in U.S. Pat.Nos. 3,671,979; 4,056,854; 4,994,077; 5,332,402; 5,370,685; 5,397,351;5,554,185; 5,855,601; and 6,168,614; U.S. Patent Application PublicationNo. 2004/0034411; Bonhoeffer P., et al., “Percutaneous Insertion of thePulmonary Valve”, Pediatric Cardiology, 2002; 39:1664-1669; Anderson HR, et al., “Transluminal Implantation of Artificial Heart Valves”, EURHeart J., 1992; 13:704-708; Anderson, J. R., et al., “TransluminalCatheter Implantation of New Expandable Artificial Cardiac Valve”, BURHeart J., 1990, 11: (Suppl) 224a; Hilbert S. L., “Evaluation ofExplanted Polyurethane Trileaflet Cardiac Valve Prosthesis”, J ThoracCardiovascular Surgery, 1989; 94:419-29; Block P C, “Clinical andHemodyamic Follow-Up After Percutaneous Aortic Valvuloplasty in theElderly”, The American Journal of Cardiology, Vol. 62, Oct. 1, 1998;Boudjemline, Y., “Steps Toward Percutaneous Aortic Valve Replacement”,Circulation, 2002; 105:775-558; Bonhoeffer, P., “TranscatheterImplantation of a Bovine Valve in Pulmonary Position, a Lamb Study”,Circulation, 2000:102:813-816; Boudjemline, Y., “PercutaneousImplantation of a Valve in the Descending Aorta In Lambs”, EUR Heart J,2002; 23:1045-1049; Kulkinski, D., “Future Horizons in Surgical AorticValve Replacement: Lessons Learned During the Early Stages of Developinga Transluminal Implantation Technique”, ASAIO J, 2004; 50:364-68; theteachings of which are all incorporated herein by reference).

Orientation and positioning of the stents of the invention may beaccomplished either by self-orientation of the stents (such as byinterference between features of the stent and a previously implantedstent or valve structure) or by manual orientation of the stent to alignits features with anatomical or previous bioprosthetic features, such ascan be accomplished using fluoroscopic visualization techniques, forexample. For example, when aligning the stents of the invention withnative anatomical structures, they should be aligned so as to not blockthe coronary arteries, and native mitral or tricuspid valves should bealigned relative to the anterior leaflet and/or thetrigones/commissures.

Some embodiments of the support structures of the stents describedherein can be a series of wires or wire segments arranged so that theyare capable of transitioning from a collapsed state to an expandedstate. In some embodiments, a number of individual wires comprising thesupport structure can be formed of a metal or other material. Thesewires are arranged in such a way that a support structure allows forfolding or compressing to a contracted state in which its internaldiameter is greatly reduced from its internal diameter when it is in anexpanded state. In its collapsed state, such a support structure withattached valves or leaflets can be mounted over a delivery device, suchas a balloon catheter, for example. The support structure is configuredso that it can be changed to its expanded state when desired, such as bythe expansion of a balloon catheter. The delivery systems used for sucha stent should be provided with degrees of rotational and axialorientation capabilities in order to properly position the stent at itsdesired location within the patient.

The wires of the support structure of the stents in other embodimentscan alternatively be formed from a shape memory material such as anickel titanium alloy (e.g., Nitinol). With this material, the supportstructure is self-expandable from a contracted state to an expandedstate, such as by the application of heat, energy, and the like, or bythe removal of external forces (e.g., compressive forces). This supportstructure can also be repeatedly compressed and re-expanded withoutdamaging the structure of the stent. In addition, the support structureof such an embodiment may be laser cut from a single piece of materialor may be assembled from a number of different components. For thesetypes of stent structures, one example of a delivery system that can beused includes a catheter with a retractable sheath that covers the stentuntil it is to be deployed, at which point the sheath can be retractedto allow the stent to expand.

Referring now to the Figures, wherein the components are labeled withlike numerals throughout the several Figures, and initially to FIGS.1-4, an exemplary embodiment of a stent 10 is illustrated. Stent 10 maybe referred to as a sub-coronary stent for use in replacement of theaortic valve in that it is preferably relatively short to enable stentplacement below the coronaries. Stent 10 may be made of a self-expandingmaterial, such as Nitinol, for example. In one embodiment, the stent 10is generally tubular in shape and can be approximately 25 mm long, forexample, although it can be longer or shorter than 25 mm, depending onthe anatomy of the patient, the preferences of the surgeon, and otherfactors. The stent 10 includes multiple longitudinal or vertical wires12 that extend generally parallel to a longitudinal axis 14 of thestent. The wires 12 are spaced from each other around the periphery ofthe generally tubular shape of the stent 10. Stent 10 further includesfeatures to which tissue can be attached to make the stent into a valve,such as commissure attachment posts 16 that can be approximately 18 mmlong, for example. The commissure attachment posts 16 each include twolongitudinal wires that are spaced closer to each other than the spacingof the wires 12 from each other.

In this embodiment, stent 10 includes three commissure attachment posts16, where each of the posts 16 is used as a connection location for oneof the commissures of a tri-leaflet valve that will be attached thereto.Alternatively, more or less than three posts 16 can be provided for avalve having more or less than three leaflets, respectively. In additionto providing the structure for attachment of commissures, the posts 16also provide additional stability to the stent 10. The wires 12 andposts 16 are preferably spaced at generally the same distance from eachother around the periphery of the stent 10, although it is contemplatedthat some of the wires 12 and/or posts 16 can be spaced at differentdistances from each other around the periphery of the stent 10. Further,the specific illustrated embodiment of stent 10 includes two wires 12positioned between two commissure attachment posts 16, although analternate embodiment may include more or less wires 12 between adjacentcommissure posts 16. However, the specific embodiment of stent 10illustrated in FIGS. 1-4 comprises nine longitudinal structures aroundits periphery, including six longitudinal wires 12 and three commissureattachment posts 16.

Stent 10 further includes multiple V-shaped wire structures between apair of wires 12 and/or between a wire 12 and an adjacent attachmentpost 16. As shown, the stent 10 includes three wires 18, 20, 22 that arelongitudinally spaced from each other along the height of the stent 10between each adjacent pair of wires 12 or between a wire 12 and anadjacent post 16. The size and shape of the wires 18, 20, 22 determinesthe spacing between adjacent longitudinal structures of the stent 10,which is generally uniform around the periphery of the stent, asdiscussed above. Although the stent 10 includes three of these V-shapedwires 18, 20, 22 that are spaced longitudinally from each other betweenadjacent vertical wire structures, there may be more or less than threeV-shaped wires spaced longitudinally from each other.

Wires 18 are positioned at a first or outlet end 24 of the stent 10. Afirst end of each wire 18 extends from a first end 26 of an attachmentpost 16 or wire 12, and a second end of wire 18 extends from the firstend 26 of an adjacent wire 12 or attachment post 16. In this way, a peak28 of each wire 18 will be positioned generally in the center of thespace between adjacent longitudinal wires, and will be directed toward asecond or inlet end 30 of the stent 10. All or some of the wires 18 canbe flared at least slightly outward relative to the outer tubular shapeof the stent 10, thereby creating integrated flange structures that canbe used to capture the native leaflets when the stent is implanted in apatient. Each wire 20 is spaced longitudinally from a corresponding wire18, and each wire 22 is spaced longitudinally from a corresponding wire20.

Additional wire structures 32 are positioned at the second end 30 of thestent 10 to correspond with each set of wires 18, 20, 22. In particular,each wire structure 32 is generally V-shaped, where the peak of each ofthe “V” structures is oriented in generally the same direction as thepeaks of the wires 18, 20, 22. A first end of each wire structure 32extends from a second end 34 of an attachment post 16 or wire 12, and asecond end of wire structure 32 extends from the second end 34 of anadjacent wire 12 or attachment post 16. All or some of the wirestructures 32 are flared at least slightly outward relative to the outertubular shape of the stent 10. The amount and angle at which the wirestructures extend relative to the tubular outer shape of the stent canbe selected for capturing native patient anatomical features. Inaddition, this flare of the wire structures 32 can help to prevent orminimize leakage between the implant and the native annulus and/or toprovide a physical and/or visual docking feature to secure the stent 10against a wall of an opening in the heart to prevent migration of thestent, for example.

The stent 10 has a relatively high-density strut pattern to containleaflets within the inner stent area during crimping of the stent. Thatis, while the exact number of longitudinal wires and V-shaped wires canvary somewhat from that illustrated in the Figures, it is preferablethat the number of wires provided is sufficient to keep the leafletmaterial from becoming compressed and potentially damaged between thestent struts during the crimping process or from protruding beyond theperiphery of the stent when it is in a crimped condition.

The first end 26 of all or some of the wires 12 and posts 16 can furtherinclude a loop or eyelet 36 that can be used for attachment to adelivery system and/or tissue valve, for example. The eyelets 36 can bein the same general plane as the outer tubular shape of the stent 10, orthey can be directed at least slightly inward toward the central area ofthe stent or at least slightly outward relative to the outer tubularsurface of the stent. The single-sided eyelet attachment end can be usedin a resheathable delivery system for both antegrade and retrogradeprocedures, for example. Attachment end crown reducers can optionally beadded to the stent to reduce the attachment crown number, although thestent would be lengthened at least slightly by such a modification.

FIG. 4 illustrates an exemplary laser cutting pattern that can be usedto form the stent 10 out of a tube or single sheet of material. Thestent 10 can alternatively be made from multiple components that areattached to each other and formed into a tubular shape. However, if thestent will be cut from a tube or single sheet of material as shown, thevarious structures will be designed so that they do not interfere witheach other in the pattern.

FIG. 26 illustrates another exemplary embodiment of a stent 50positioned for clarity on a mandrel, which also may be referred to as asub-coronary stent in that it is preferably relatively short (e.g., 25mm long) to enable stent placement below the coronary arteries in theaorta. This stent includes a number of the same features as the stent ofFIGS. 1-4, although this stent 50 does not include the integrated petalsshown and described above relative to stent 10. Rather, the V-shapedstructures 52 at the outlet end of the stent 50 are generally in thesame plane as the tubular outer shape of the stent 50 (i.e., thestructures 52 are not flared outwardly). The stent 50 also includeseyelets 54 at the outlet end of the stent, which can be in the samegeneral plane as the outer tubular shape of the stent 50, or they can bedirected at least slightly inward or at least slightly outward relativeto the outer tubular shape of the stent 50.

FIGS. 5-8 illustrate another exemplary embodiment of a stent 60, whichis similar in structure to the stent 10 described above, including awire structure with multiple commissure attachment posts 62. These posts62 include two vertical struts that are spaced at least slightly fromeach other. These posts 62 further include multiple horizontal members64 that are spaced from each other along the length or height of eachpost 62. The spaces or openings 66 that are created between thehorizontal members 64 provide locations through which suture material,needles, and/or other fastening materials can be inserted for attachmentof leaflet or valve material to the stent at the commissure posts. Inaddition, the horizontal members 64 can be used as defined anchoringpoints for the fastening materials. For example, a suture material canbe inserted through a first opening 66 and then through another opening66 in a predetermined pattern to stitch valve material to the commissureattachment posts 62. The horizontal members 64 can further be used asanchoring structures that keep sutures or other attachment mechanismsfrom moving vertically past a certain position along the attachmentposts 62.

Another embodiment of a stent 80 is illustrated in FIGS. 9 and 10, whichhas a similar structure to stent structures described above relative totubular stent constructions. Stent 80 further includes a scaling skirt82 at its inlet end 84. The sealing skirt 82 can provide for improvedsealing between the stent 80 and the anatomy in which the stent 80 isplaced, such as the annulus of a valve, for example. The sealing skirt82 can be configured to unfurl away from the inlet end 84 of the valveand into the delivery system that was used to deliver the stent 80, ifdesired. In this way, the material used to make the sealing skirt 82does not increase the overall size of the stent 80 when it is crimped orcompressed. The sealing skirt 82 can further be provided withradiopaque, echogenic properties or other visually detectable propertiesso that an operator can assess the proper positioning of the stent 80 inthe patient's anatomy prior to releasing it from the delivery system.

A number of systems, components, and devices are described below forattachment of valve material (e.g., tissue leaflets) within the interiorarea of a stent structure. It is understood that the systems that areshown and described herein for this purpose can be used with stentconfigurations described above and/or other stent constructions.

In one exemplary embodiment, a tubular stent structure includes at leastone commissure post, along with a first leaflet and a second leaflet.Leaflets are attached or sewn to the post using suture material. In thisembodiment, a tissue “cushion” is provided on both sides of thecommissure attachment post to help absorb and distribute stress awayfrom the stitch points and to minimize tissue abrasion that can becaused without such protection. In this configuration, the leaflets 104,106 can flex along the tissue and the leaflet/tissue seam line and thetissue cushion distributes stress from flexing during opening andclosing of leaflets away from the suture points where leaflets areattached into the attachment post.

Another configuration and device that can be used in the attachment ofvalve material to a stent structure is shown and described relative toFIGS. 11-14. In particular, a relatively rigid “ladder” member 120 isprovided to support the leaflet commissure area and transfer the line orpoint about which the leaflets 140 flex or bend to a location that isspaced from the suture line. In this way, the stresses can be moreevenly distributed and durability of the valve improved. Ladder member120 includes a relatively flat elongated plate 122 having multiple holesor openings 124 along its length. In order to minimize or prevent damageto the tissue of the valve, the corners and edges of the ladder member120 are preferably rounded or smoothed. The holes 124 are preferablyspaced from each other by a distance that corresponds with a desiredstitching pattern that will be used to both secure the member 120 to thestent structure and attach the leaflets. It is further contemplated thatthe ladder member 120 is configured to match specific commissurefeatures of the stent.

FIGS. 12 and 13 illustrate two ladder members 120 positioned relative toa portion of a stent 126 and portions of two leaflets. In particular,portions 128, 129 of adjacent leaflet commissures are secured in thespace between two ladder members 120. The ladder members 120 are spacedfrom each other by a distance that allows the components to be securelyfastened to each other, but that accommodates the thickness of theleaflets that are positioned between them. Additional material from theleaflets extends around the ends of the ladder members 120 between theedge of the ladder members 120 and the stent 126, then along theoutwardly facing sides of the ladder members 120, such as is indicatedby the reference number 130. This additional material provides forimproved security in tissue attachment and also provides additionalattachment locations.

Sutures 132 can be inserted through the tissue material to secure it tothe ladder members 120, where one exemplary stitching pattern isillustrated in FIG. 15. An appropriate number of stitches should be madethrough the tissue material and ladder member 120 to securely attach theladder members 120 to the leaflets. The same or a different suturematerial can be used to attach or position adjacent ladder members 120relative to each other. Additional sutures or an extension of the sewingpattern can also be used to connect the ladder members 120 to the stent126. The suture pattern can follow the holes in the ladder member 120such that the ladder member 120 provides a template for sewing theleaflet tissue to the ladder members 120, or an alternate stitchingpattern can be used. The leaflets can then flex against a long verticaledge 134 of each of the ladder members 120, thereby transferring thestress away from the attachment suture line.

FIG. 14 illustrates another tissue attachment arrangement that includesthe use of two ladder members 120, as described above, along withadditional protective layers 136. Each protective layer 136 can providesupplemental padding between a ladder and the adjacent leaflet material,and can also provide additional strength at the attachment sites. Theprotective layers 136 can be made of a material such as cloth, tissue,polymeric sheets, or the like. As shown, one protective layer 136 isused for each of the ladder members 120, with the protective layer 136being positioned between each ladder member 120 and its correspondingleaflet 128, 129. Each protective layer 136 can wrap around at least aportion of the periphery of its corresponding ladder member 120, and inone embodiment will wrap around almost the entire periphery of theladder members 120, as shown. Further, each protective layer 136 canextend along the entire length or height of its corresponding ladder120, or it may extend along only a portion of the length of the laddermember 120. An exemplary pattern of stitching the components to eachother and to the stent 126 is illustrated with the sutures 132 (shown asbroken lines), although a different stitching pattern can instead beused.

Another configuration and device that can be used in the attachment ofvalve material to a stent structure is shown and described relative toFIGS. 15-17. In particular, a relatively rigid “slot bar” member 150 isprovided to support the leaflet commissure area and transfer the line orpoint about which the leaflets flex or bend to a location that is spacedfrom the suture line. In this way, the stresses can be more evenlydistributed. Slot bar member 150 includes a relatively flat elongatedplate 152 having a longitudinal slot 156 extending along a portion ofits length, and multiple holes or openings 154 along the length of themember 150 on both sides of the slot 156. Alternatively, one or bothends could be open and/or two separate portions can make up the slot barmember. In order to minimize or prevent damage to the tissue of thevalve, the corners and edges of the slot bar member 150 are preferablyrounded or smoothed. The holes 154 are preferably spaced from each otherby a distance that corresponds with a desired stitching pattern thatwill be used to both secure the member 150 to the stent structure andthe tissue to the slot bar. It is further contemplated that the slot barmember 150 is configured to match specific commissure features of thestent to which it will be attached. In addition, the width of the slot156 is preferably selected based on the thickness of the leaflets thatwill be inserted through the slot 156. Thus, the slot 156 should be wideenough to accommodate two thicknesses of leaflet material; however, theslot 156 may be designed for more layers of material or for an optimizedcompression fit, if desired. In order to provide secure positioning ofthe tissue layers within the slot 156 and to minimize the potential forthe tissue to be pulled from the slot 156, the slot should not besubstantially wider than the thickness of the materials that will bepositioned within it.

FIGS. 16-17 illustrate slot bar member 150 positioned relative to aportion of a stent 158 and portions of two leaflets 160, 162. Inparticular, the end portions of adjacent leaflet commissures 160, 162are pulled through the slot 156 by a sufficient distance that the freeedge of each of the leaflets extends at least slightly past the holes154 on the flat side of the plate 152. This end portion of the leaflets160, 162 will thereby be positioned between the slot bar member 150 andthe stent to which they will be attached. In this way, the leaflets 160,162 can be securely fastened to the slot bar member 150 and the stent158. Sutures 164 can then be inserted through the tissue material tosecure it to the slot bar member 150, where one exemplary stitchingpattern is illustrated in FIGS. 16 and 17. The stitching pattern canfollow the holes 154 in the slot bar member 150 such that the slot barmember 150 provides the template for sewing the leaflet tissue to theslot bar member 150, or an alternate stitching pattern can be used. Thesutures 164 can thereby connect the slot bar member 150 to the leaflets160, 162. Additional sutures or the same sutures can also be used toconnect the slot bar member 150 to the stent 158. The leaflets 160, 162can then flex over a long vertical edge 166 on each side of the slot barmember 150 during valve leaflet opening and closing, therebytransferring the stress away from the attachment suture line andincreasing the durability of the valve.

FIGS. 18 and 19 illustrate another tissue attachment arrangement thatincludes the use of a slot bar member 150 of the type described above,along with additional protective members 170, 172. Protective members170, 172 are positioned on opposite sides of the slot 156 of the slotbar member 150 so that each of the members 170, 172 can protect one ofthe leaflets 160, 162. Each protective member 170, 172 can provideadditional padding or cushioning between one of the leaflets 160, 162and the slot bar member 150 during opening and closing of the leaflets.The protective members 170, 172 can be made of a material such as cloth,tissue, polymeric sheets, or the like. Further, each protective member170, 172 can extend along the entire length of its corresponding slotbar member 150, or it may extend along only a portion of the length ofthe slot bar member 150. An exemplary pattern of stitching thecomponents to each other and to the stent 158 is illustrated with theschematic representation of a suture 164, although a different stitchingpattern can instead be used. The suture material can be used to attachthe excess tissue material to only the slot bar member 150, if desired.Alternatively, the protective members on the leaflet side of the slotbar member could be extended circumferentially beyond the slot barmember and attached to the stent (not shown). In this way, the leafletwould be prevented from contacting the suture material during opening ofthe valve reducing the potential for leaflet abrasion and tearing. Inorder to accommodate the thickness of the extra layers provided by theprotective members 170, 172, the slot 156 should have an appropriatewidth.

Another configuration and device that can be used in the attachment ofvalve material to a stent structure is shown and described relative toFIGS. 20-22. In particular, a relatively rigid “buckle” member 180 isprovided to support the leaflet commissure area and transfer the line orpoint about which the leaflets flex or bend to a location that is spacedaway from the suture line. In this way, the stresses can be more evenlydistributed increasing the durability of the valve. Buckle member 180includes a relatively flat elongated plate 182 having a longitudinalslot 184 extending along a portion of its length. The slot couldalternatively be open at either one or both ends of the plate. In orderto minimize or prevent damage to the tissue of the valve, the cornersand edges of the buckle member 180 are preferably rounded or smoothed.The width of the slot 184 is preferably selected based on the thicknessof the layers of material that will be inserted through the slot 184.Thus, the slot 184 should be wide enough to accommodate the twothicknesses of leaflet material that will extend through it, asdescribed below; however, the slot 184 may be designed for more layersof material or for an optimized compression fit, if desired. In order toprovide secure positioning of the tissue layers within the slot 184 andto minimize the potential for the tissue to be pulled from the slot 184,the slot should not be substantially wider than the width of thematerial that will be positioned within it.

As shown in the Figures, the buckle member 180 is positioned on theopposite side of a stent 194 than the other embodiments discussed above(i.e., on the outer side of the stent structure rather than on the innerside of the stent structure). In this embodiment, the stent 194 has avertical slot 186 in its commissure post that generally corresponds tothe slot 184 in the buckle member 180. The end portions of two leaflets190, 192 are pulled through the slot 186 in the stent commissure post,then through the slot 184 in the buckle member 180. The ends of theleaflets are then wrapped around the back side of the buckle member 180and pulled back through the slot 186 in the commissure post in theopposite direction than the first insertion of the leaflets through thisslot 186. The leaflets 190, 192 should continue to be pulled through theslot 186 by a sufficient distance that the free edge of each of theleaflets 190, 192 extends at least slightly past the structure of thestent in the internal area of the stent. With this arrangement, theleaflets 190, 192 will flex generally along a vertical line 196, whichis the tissue that covers a vertical edge of the stent. In thisembodiment, no sutures are required for attachment of the leaflets 190,192 to the stent and/or the buckle member 180. Rather, the force on thecommissure caused by the closing of the leaflets 190, 192 will cause thebuckle member 180 to be pressed toward the stent, thereby compressingand locking the excess tissue material between the buckle member and thestent. This secures the commissure and prevents the tissue material ofthe leaflets from pulling out of the assembly.

FIGS. 23-25 illustrate another configuration and device for theattachment of valve material to a stent structure that includes the useof a buckle member 200 that is similar in design and operation to thebuckle member 180 discussed above. In this embodiment, however, thebuckle member 200 includes two longitudinal slots 202, 204 that arespaced from each other across the width of the buckle member 200, ratherthan a single, central slot. In this way, a first leaflet 206 can bepulled through a longitudinal slot 210 in the stent and throughlongitudinal slot 202 of the buckle member 200, and a second leaflet 208can be pulled through a longitudinal slot 210 in the stent and throughlongitudinal slot 204 of the buckle member 200. The leaflets 206, 208can then be wrapped around the back side of the buckle member 200,pulled back through the longitudinal slot 210 in the commissure post,and pulled through the slot by a sufficient distance that the leafletscan be secured to the stent without stitching, similar to thearrangement that uses the buckle member 180.

It is noted that in many of the stent embodiments shown and describedherein, the aspect ratio of certain portions of the stent can besomewhat different from that shown. Further, stent embodiments describedherein may be modified to include additional structure for attachment oftissue for the valve, such as the vertical stent posts described in manyof the embodiments.

Delivering any balloon-expandable stents of the invention to theimplantation location can be performed percutaneously. In general terms,this includes providing a transcatheter assembly, including a deliverycatheter, a balloon catheter, and a guide wire. Some delivery cathetersof this type are known in the art, and define a lumen within which theballoon catheter is received. The balloon catheter, in turn, defines alumen within which the guide wire is slideably disposed. Further, theballoon catheter includes a balloon that is fluidly connected to aninflation source. It is noted that if the stent being implanted is theself-expanding type of stent, the balloon would not be needed and asheath or other restraining means would be used for maintaining thestent in its compressed state until deployment of the stent, asdescribed herein. In any case, for a balloon-expandable stent, thetranscatheter assembly is appropriately sized for a desired percutaneousapproach to the implantation location. For example, the transcatheterassembly can be sized for delivery to the heart valve via an opening ata carotid artery, a jugular vein, a sub-clavian vein, femoral artery orvein, or the like. Essentially, any percutaneous intercostalspenetration can be made to facilitate use of the transcatheter assembly.

Prior to delivery, the stent is mounted over the balloon in a contractedstate to be as small as possible without causing permanent deformationof the stent structure. As compared to the expanded state, the supportstructure is compressed onto itself and the balloon, thus defining adecreased inner diameter as compared to an inner diameter in theexpanded state. While this description is related to the delivery of aballoon-expandable stent, the same basic procedures can also beapplicable to a self-expanding stent, where the delivery system wouldnot include a balloon, but would preferably include a sheath or someother type of configuration for maintaining the stent in a compressedcondition until its deployment.

With the stent mounted to the balloon, the transcatheter assembly isdelivered through a percutaneous opening (not shown) in the patient viathe delivery catheter. The implantation location is located by insertingthe guide wire into the patient, which guide wire extends from a distalend of the delivery catheter, with the balloon catheter otherwiseretracted within the delivery catheter. The balloon catheter is thenadvanced distally from the delivery catheter along the guide wire, withthe balloon and stent positioned relative to the implantation location.In an alternative embodiment, the stent is delivered to an implantationlocation via a minimally invasive surgical incision (i.e.,non-percutaneously). In another alternative embodiment, the stent isdelivered via open heart/chest surgery. In one embodiment of the stentsof the invention, the stent includes a radiopaque, echogenic, or MRIvisible material to facilitate visual confirmation of proper placementof the stent. Alternatively, other known surgical visual aids can beincorporated into the stent. The techniques described relative toplacement of the stent within the heart can be used both to monitor andcorrect the placement of the stent in a longitudinal direction relativeto the length of the anatomical structure in which it is positioned.

Once the stent is properly positioned, the balloon catheter is operatedto inflate the balloon, thus transitioning the stent to an expandedstate. Alternatively, where the support structure is formed of a shapememory material, the stent can self-expand to its expanded state.

The present invention has now been described with reference to severalembodiments thereof. The foregoing detailed description and exampleshave been given for clarity of understanding only. No unnecessarylimitations are to be understood therefrom. It will be apparent to thoseskilled in the art that many changes can be made in the embodimentsdescribed without departing from the scope of the invention. Thus, thescope of the present invention should not be limited to the structuresdescribed herein.

1-15. (canceled) 16: A prosthetic valve comprising: a valve supportincluding, a first end, a second end, an interior area, a longitudinalaxis, a plurality of posts extending generally parallel to thelongitudinal axis around a periphery of the valve support, wherein theplurality of posts include a plurality of commissure posts, and aplurality of struts extending circumferentially around the longitudinalaxis and connecting the plurality of posts together; an outer memberattached to the first end or the second end of the valve support, theouter member having a free end not attached to the valve support; anannular space disposed between an outer surface of the valve support andan inner surface of the outer member; and a valve structure attachedwithin the valve support. 17: The prosthetic valve of claim 16, whereinthe valve structure includes a plurality of leaflets, wherein eachleaflet is attached at a first end to a first commissure post of theplurality of commissure posts and is attached at a second end to asecond commissure post of the plurality of commissure posts. 18: theprosthetic valve of claim 16, wherein the valve structure includes aplurality of leaflets, wherein a first end of a first leaflet of theplurality of leaflets is attached to a first commissure post of theplurality of commissure posts, and wherein a second end of a secondleaflet of the plurality of leaflets is attached to the first commissurepost. 19: The prosthetic valve of claim 18, wherein a second end of thefirst leaflet is attached to a second commissure post of the pluralityof commissure posts, wherein a first end of the second leaflet isattached to the second commissure post. 20: The prosthetic valve ofclaim 18, wherein a second end of the first leaflet is attached to asecond commissure post of the plurality of commissure posts, wherein afirst end of a third leaflet is attached to a second commissure post ofthe plurality of commissure posts, wherein a second end of the thirdleaflet is attached to a third commissure post of the plurality ofcommissure posts, and wherein a first end of the second leaflet isattached to the third commissure post. 21: The prosthetic valve of claim16, wherein the outer member comprises a sealing skirt. 22: A prostheticvalve comprising: a valve support including, a first end, a second end,an interior area, a longitudinal axis, a plurality of posts extendinggenerally parallel to the longitudinal axis around a periphery of thevalve support, wherein the plurality of posts include a plurality ofcommissure posts, wherein each of the plurality of commissure postsincludes a first strut parallel to the longitudinal axis and a secondstrut parallel to the longitudinal axis, wherein the first strut and thesecond strut are spaced circumferentially from each other to form alongitudinal gap between the first strut and the second strut, and aplurality of struts extending circumferentially around the longitudinalaxis and connecting the plurality of posts together; and a valvestructure attached within the valve support to the plurality ofcommissure posts. 23: The prosthetic valve of claim 22, wherein thevalve support further includes a plurality of transverse membersextending across the longitudinal gap between the first strut and thesecond strut of respective commissure posts of the plurality ofcommissure posts, wherein the plurality of transverse members are spacedlongitudinally such that the longitudinal gap is separated into aplurality of longitudinal gaps. 24: The prosthetic valve of claim 22,wherein each of the plurality of struts extending circumferentiallyincludes a first end coupled to a first post of the plurality of posts,a second end coupled to a second post of the plurality of posts adjacentto the first post, and at least one peak between the first end and thesecond end. 25: The prosthetic valve of claim 24, wherein each peakextends towards the first end of the valve support. 26: The prostheticvalve of claim 22, wherein the plurality of struts extendingcircumferentially around the longitudinal axis includes a plurality ofrows of struts, the plurality of rows spaced longitudinally from eachother. 27: The prosthetic valve of claim 22, further comprising an outermember attached to the first end or the second end of the valve support,an inner surface of the outer member being spaced radially from an outersurface of the valve support. 28: The prosthetic valve of claim 27,wherein the outer member includes a first end attached to the first endor second end of the valve support and a second end not attached to thevalve support. 29: The prosthetic valve of claim 27, wherein the outermember is a sealing skirt. 30: A prosthetic valve comprising: a valvesupport structure including a first end, a second end, an interior area,a longitudinal axis, and a plurality of longitudinal wires extendinggenerally parallel to the longitudinal axis around a periphery of thevalve support structure, wherein the plurality of longitudinal wiresincludes multiple commissure structures and at least one structural wirepositioned between adjacent commissure structures, and at least threerows of V-shaped wire structures having a first end, a second end, and apeak between the first and second ends, wherein a first end of eachV-shaped structure extends from a first longitudinal wire and a secondend of each V-shaped structure extends from a second longitudinal wirethat is adjacent to the first longitudinal wire; and a valve structureattached to the valve support structure within the interior area of thevalve support structure, the valve structure comprising a plurality ofleaflets, a first end of each of the plurality of leaflets attached to arespective one of the multiple commissure support structures and asecond end of each leaflet attached to a respective different one of themultiple commissure support structures. 31: The prosthetic valve ofclaim 30, wherein the peaks are all oriented in the same direction. 32:The prosthetic valve of claim 30, further comprising an outer memberattached to the first end of the valve support structure, wherein aninner surface of the outer member is spaced radially from an outersurface of the valve support structure. 33: The prosthetic valve ofclaim 32, wherein the outer member includes a first end attached to thefirst end of the valve support structure and a second end that isunattached to the valve support structure. 34: The prosthetic valve ofclaim 32, wherein the outer member is a sealing skirt.